CI

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ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01105689
NCT01105689N/ACompleted

Utility of the Urine Calcium Creatinine Ratio as a Screening Tool for Vitamin D Deficiency in Infants and Toddlers

Nemours Children's Clinic·observational·Posted Apr 16, 2010·Updated Sep 9, 2011

In Brief

An observational study for Vitamin D Deficiency. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Background: Vitamin D plays a key role in calcium absorption in the gut and in skeletal development. Vitamin D deficiency is common, affecting an estimated one billion people worldwide, including developed countries. Vitamin D deficiency causes rickets, the most common non-communicable disease of childhood. Rickets causes poor growth and skeletal deformities and, at its most severe, seizures and death. Recent data suggest that children with rickets have an increased risk for developing diabetes mellitus. Screening for vitamin D deficiency is not commonly done. It is generally diagnosed only after symptoms of rickets have developed. Prevention and treatment is simple and inexpensive. Hence, early detection of vitamin D deficiency through screening would be beneficial. Studies are urgently needed to validate such screening tests. Calcium balance is tightly regulated in the body and calcium loss in the urine (measured by the urine calcium-to-creatinine ratio) is a sensitive indicator of reduced calcium absorption, such as in vitamin D deficiency. Objective and Hypotheses. The objective of this study is to evaluate the urine calcium-to-creatinine ratio as a noninvasive and inexpensive screening test for vitamin D deficiency. Our hypotheses are 1) that the urine calcium-to-creatinine ratio correlates with blood vitamin D levels in infants and toddlers at risk for vitamin D deficiency and 2) that this test can be used to screen for vitamin D deficiency. Potential Impact. A validated screening tool would allow for the detection of vitamin D deficiency before the development of rickets, decreasing the morbidity and mortality of this common disease.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 16, 2010
Enrollment StartMar 1, 2010
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.2 years ago